Interest of the Manual Exploration as a Supplement to the Coelioscopy in the Evaluation of the Resectability of Peritoneal Carcinosis

NCT ID: NCT02493972

Last Updated: 2019-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-07-31

Brief Summary

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This is a Multicenter prospective diagnostic study.

Detailed Description

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Conditions

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Ovarian Cancer With Peritoneal Carcinosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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manual exploration by GelPort

manual exploration in supplement of coelioscopy before laparotomy

Group Type EXPERIMENTAL

GelPort

Intervention Type PROCEDURE

Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability

laparotomy

Intervention Type PROCEDURE

laparotomy will be performed if indication confirmed by manual exploration

Interventions

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GelPort

Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability

Intervention Type PROCEDURE

laparotomy

laparotomy will be performed if indication confirmed by manual exploration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Over 18 years of age Patient
* Woman presenting a peritoneal carcinosis presumed ovarian origin
* Coelioscopy (1st intent or recurrence) planned or performed in the last 4 weeks for laparotomy. The peritoneal cancer index of Sugarbaker must be available.
* WHO 0 - 2
* Membership in a social security system
* Patient having given her written consent

Exclusion Criteria

* Male
* Contraindication in the coelioscopy
* Any associated medical or psychological condition which could compromise the capacity of the patient to participate in the study
* Patient deprived of freedom, under guardianship or guardianship
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Groupement Interrégional de Recherche Clinique et d'Innovation

OTHER

Sponsor Role collaborator

Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU

Amiens, , France

Site Status

Centre Françis Baclesse

Caen, , France

Site Status

CHU

Caen, , France

Site Status

Institut de Cancérologie de l'Ouest

Nantes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00615-44

Identifier Type: -

Identifier Source: org_study_id

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